A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Trial Information

A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Primary Objective:

- To determine the Progression Free Survival (PFS) in patients with metastatic breast
cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).

Secondary Objective(s):

- To determine the objective response rate in both arms.

- To determine the duration of response in both arms.

- To determine the Time to Progression (TTP) in both arms.

- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in
both arms.

- To determine the overall survival rate 3 years after "Last Patient In".

- To determine PFS and TTP response rates in patient's ≥ age 65.

- To determine the toxicity and compliance in both arms.

- To determine the predictive value of serum markers such as VEGF.

Inclusion Criteria:

- ECOG performance status 0-2

- Histological confirmed carcinoma of the breast with no over expression of HER2

- Locally advanced or metastatic stage of disease not suitable for surgery or
radiotherapy alone

- Patients must have either measurable or non-measurable target lesions according to
RECIST criteria (phase III). Complete staging work-up within 4 weeks prior to
registration. All patients must have chest X-ray (PA and lateral), abdominal
ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone
X-ray is mandatory. Other tests may be per- formed as clinically indicated

- The following previous systemic treatment are eligible:

- (neo)adjuvant chemotherapy (except if capecitabine was included) However if
(neo)adjuvant chemotherapy was anthracycline based, the maximum cumulative dose of
prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2
for epirubicin. If taxanes or capecitabine were part of (neo)adjuvant treatment, a
treatment-free interval of > 6 months is requested

- adjuvant endocrine therapy.

- palliative endocrine treatments

- treatment with bisphosphonates

- treatment with immunotherapies

- Patient has to be fully recovered from previous radiotherapy. At least one measurable
lesion must be completely outside the radiation field or there must be pathologic
proof of progressive disease

- Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with
increased bleeding risk, or treatment with anticoagulants Current or recent (within
10 days of first dose of bevacizumab) use of acetylic acid (>325mg/day) or
clopidogrel (> 75mg/day)

- Major surgery within the last 28 days or anticipation of the need for major surgery
during study treatment with bevacizumab. No minor surgeries including insertion of an
indwelling catheter within 24 h prior to randomization

Type of Study:

Study Design:

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"

Outcome Time Frame:

10 month

Safety Issue:

Yes

Principal Investigator

Hans-Joachim Lück, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

German Breast Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 43

NCT ID:

NCT01200212

Start Date:

July 2009

Completion Date:

October 2012

Related Keywords:

Breast Cancer

Palliative Therapy

bevacizimab

Avastin

Xeloda

metastatic breast cancer

Progression Free Survival

Time to Progression

Overall survival

Breast Neoplasms

Name

Location

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